New University of Michigan Tinnitus Discovery — Signal Timing

Discussion in 'Research News' started by Hudson, Jun 20, 2013.

    1. TomBradyGOAT

      TomBradyGOAT Member

      Tinnitus Since:
      2016
      Cause of Tinnitus:
      Who knows
      Didn't De Ridder question Dr. Shore's approach for improving tinnitus? If Lenire got approved in the US, then De Ridder could piggy back off that to get faster approval. It is easier to get devices approved once another one has, that is "close" to an already approved device.
       
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    2. Chinmoku

      Chinmoku Member Benefactor Hall of Fame

      Tinnitus Since:
      10/2018
      Cause of Tinnitus:
      Started with a cold, possibly worsened by medication/noise
      I was reading about 510(k), Greg. It looks like after the quiet phase there will be some back and forth on possible technical questions with a 180 days response limit. Who knows when this will hit the market, let's hope soon for all extreme sufferers. A big hug, my friend.
       
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    3. Chinmoku

      Chinmoku Member Benefactor Hall of Fame

      Tinnitus Since:
      10/2018
      Cause of Tinnitus:
      Started with a cold, possibly worsened by medication/noise
      I'm still trying to read the FDA documentation. It's very hard with this scream from hell in my ears, sleep deprivation and 24/7 torture make it very hard. I think for all parts concerned De Ridder should complete a clinical trial first, especially for a Class III device. He has one going on in Delft, apparently. Then probably, as you say, the fact that similar bimodal neuromodulation devices would have been approved earlier could simplify some aspects of the FDA approval process, but if the clinical trial results weren't good enough it would be kind of pointless. So it all really boils down to how good the Delft trial results will be. Also, I don't know how long De Ridder has been working consistently on bimodal neuromodulation. Shore has been working consistently on it for a long time.
       
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    4. kingsfan
      Mellow

      kingsfan Member Benefactor Hall of Fame

      Location:
      Southern California
      Tinnitus Since:
      9-17-20 / 10-20-20 / 3-31-21 / 5-23-21
      Cause of Tinnitus:
      turning everything up to 11
      Simply hearing positive results is all I am concerned with at the moment. I feel that knowing it is effective may be enough to keep myself and others hanging on through the process of FDA approval. But this waiting for journal publication nonsense leaves a sour taste in my mouth when the results are right in front of them. If she really is in this to help suffering, and it isn't just some academic flex, why not throw us a bone?
       
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    5. ploughna

      ploughna Member

      Tinnitus Since:
      2017
      Cause of Tinnitus:
      motor racing and power tools
      Where are the 100s of people that took part I wonder - all sworn to secrecy I assume! But I agree, the waiting game can be tough to take. I just try not to think about it and deal with it myself as best I can.
       
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    6. Gb3

      Gb3 Member

      Tinnitus Since:
      12/19
      Cause of Tinnitus:
      Sshl
      She responded to this in her email update. She can’t. What is so hard to understand about that.
       
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    7. kingsfan
      Mellow

      kingsfan Member Benefactor Hall of Fame

      Location:
      Southern California
      Tinnitus Since:
      9-17-20 / 10-20-20 / 3-31-21 / 5-23-21
      Cause of Tinnitus:
      turning everything up to 11
      Many things are hard to understand when your head is screaming at you.
       
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    8. Padraigh Griffin

      Padraigh Griffin Member Podcast Patron Benefactor

      Tinnitus Since:
      05/2020
      Cause of Tinnitus:
      Unknown/Stress
      De Ridder questioned to me what happens when the treatment ends with the Shore device? I was like thinking 'you just keep using it' but I didn't answer like that to the Professor. I have a Zoom with the Professor coming up and will discuss research the best I can.
       
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    9. Tomas80

      Tomas80 Member

      Tinnitus Since:
      10/2018
      Cause of Tinnitus:
      Unknow. Maybe stress?
      Do you know what I think? If a person's tinnitus worsened during testing the device, their anger would be stronger than a non-disclosure agreement and they would complain under a pseudonym. No complaints yet, so at least I believe we will not risk aggravation of our tinnitus. Or?
       
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    10. DebInAustralia
      No Mood

      DebInAustralia Member Benefactor Hall of Fame Advocate

      Location:
      Geelong, Victoria
      Tinnitus Since:
      12/2013
      Sorry if it is obvious, but is Dr. Shore's trial now due to end in July?
       
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    11. UHPTS
      Wishful

      UHPTS Member

      Tinnitus Since:
      October 2019
      Cause of Tinnitus:
      Ear infection
      July what year?
       
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    12. Chinmoku

      Chinmoku Member Benefactor Hall of Fame

      Tinnitus Since:
      10/2018
      Cause of Tinnitus:
      Started with a cold, possibly worsened by medication/noise
      That's what I understood to be the new expected end date. Emphasis on expected.
       
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    13. DaveFromChicago

      DaveFromChicago Member Podcast Patron Benefactor

      Tinnitus Since:
      01/2014
      Cause of Tinnitus:
      Headcold/Flu
      Should we all pitch in with donations so that I can retain a Private Investigator (and as an Insurance Adjuster I know of a really good one, like Jack Nicholson in "Chinatown") to visit Ann Arbor, MI and see if he can persuade some of these participants (were there actually 400?) to divulge their experiences with this?

      This PI is one of those people who can chat up a person and within 10 minutes have him/her giving out phone numbers, physical and e-mail addresses, names of relatives, etc. Perhaps he could even work his methods on Dr. Shore to get real answers.

      Just kidding; I dread the legal ramifications that could be cited against me if I really did this.
       
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    14. TomBradyGOAT

      TomBradyGOAT Member

      Tinnitus Since:
      2016
      Cause of Tinnitus:
      Who knows
      Who says the treatment ends? Diabetics will always take insulin.
       
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    15. Chinmoku

      Chinmoku Member Benefactor Hall of Fame

      Tinnitus Since:
      10/2018
      Cause of Tinnitus:
      Started with a cold, possibly worsened by medication/noise
      Private Investigation
      (refashioned after Dire Straits)

      It's a mystery to me
      The game commences
      For the usual fee
      Plus expenses
      Confidential information
      It's in a trial
      This is my investigation
      For the suicidal

      I go checking out the reports
      Digging up the dirt
      You get to meet all sorts
      In this line of work
      Delay and procrastination
      There's always an excuse for it
      I read FDA documentation
      And I still can't get used to it

      And what have you got
      At the end of the day?
      What have you got
      To take away?
      A bottle of benzos
      And a new set of fears
      Blinds on a window
      And a scream inside the ears

      Scarred for life
      No compensation
      Private investigations

      Original song (hyperacusis/noxacusis people be careful)
       
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    16. Bruce NH USA

      Bruce NH USA Member Benefactor

      Location:
      New Hampshire, United States
      Tinnitus Since:
      1981; intolerable since 11/2021
      Cause of Tinnitus:
      Loud music, then ototoxic drug (Paxil)
      Brilliant!
       
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    17. Padraigh Griffin

      Padraigh Griffin Member Podcast Patron Benefactor

      Tinnitus Since:
      05/2020
      Cause of Tinnitus:
      Unknown/Stress
      Yep. My point exactly but I am just saying what Professor De Ridder said to me. I have a Zoom again in 6 days. I will mention it again.
       
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    18. InNeedOfHelp

      InNeedOfHelp Member

      Tinnitus Since:
      08/2021
      Cause of Tinnitus:
      MRI Scan
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    19. IntotheBlue03

      IntotheBlue03 Member

      Location:
      Philadelphia PA
      Tinnitus Since:
      12/2021
      Cause of Tinnitus:
      Cervical/TBD
      Hi all,

      Hate to bother everyone but very much struggling still between my severe visual issues and spiking tinnitus currently.

      Can anyone advise where we are with Dr. Shore timeline wise?
       
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    20. Uklawyer

      Uklawyer Member

      Tinnitus Since:
      03/2020
      Cause of Tinnitus:
      Medication - antidepressants
      @IntotheBlue03, not very far, unfortunately. The gist of it is: it will be done when it's done. Apparently, they want to take their time and not rush anything because they are professionals. They have to fully unblind and then present the results in a recognised medical journal. Until then, we are not permitted to know the results.

      Hang on in there.
       
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    21. DebInAustralia
      No Mood

      DebInAustralia Member Benefactor Hall of Fame Advocate

      Location:
      Geelong, Victoria
      Tinnitus Since:
      12/2013
      A friend reached out to Dr. Shore about the trial ending in July. This is what she responded:
       
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    22. IntotheBlue03

      IntotheBlue03 Member

      Location:
      Philadelphia PA
      Tinnitus Since:
      12/2021
      Cause of Tinnitus:
      Cervical/TBD
      Hey @Uklawyer,

      Nice to hear from you. Are the rumors true that they won’t be releasing the preliminary results until after the peer review? Guessing that could land us in 2023.
       
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    23. InNeedOfHelp

      InNeedOfHelp Member

      Tinnitus Since:
      08/2021
      Cause of Tinnitus:
      MRI Scan
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    24. Uklawyer

      Uklawyer Member

      Tinnitus Since:
      03/2020
      Cause of Tinnitus:
      Medication - antidepressants
      Apparently, there will not be any "preliminary results" - just final results.

      @ajc posted the following response from Dr. Shore:

      "Sharing Results from the Second Human Trial

      We understand the desire to know results as soon as possible, but the release of clinical-trial results is constrained. First, as reputable scientists, we will publish the findings in a relevant journal after proper peer review. Second, regulatory agencies (e.g., FDA, NIH) are careful in their reviews of novel therapies, as they should be, so all of us must be patient."​

      I have no idea how long that could take, nor why this process must be followed :(
       
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    25. IntotheBlue03

      IntotheBlue03 Member

      Location:
      Philadelphia PA
      Tinnitus Since:
      12/2021
      Cause of Tinnitus:
      Cervical/TBD
      Thanks @Uklawyer. I am quite disappointed in this as I don’t see why the two can’t be decoupled on separate tracks (FDA and peer review). It seems more knowledgeable people than me have confirmed this as a possible avenue in the past. At this rate I don’t even know if I will be alive to hear about the results. I really hope Dr. Shore isn’t taking this route to save face because the results aren’t good. I can’t wrap my mind around the rush to commercialize and then this slow walking at the end of the study. As other people have said, it would be great to have confirmed good results to look forward to.
       
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    26. InNeedOfHelp

      InNeedOfHelp Member

      Tinnitus Since:
      08/2021
      Cause of Tinnitus:
      MRI Scan
      Susan Shore co authored a report which is not peer reviewed yet but already available just a week ago, see a few posts above. Yes, it gets published in a journal but it does not say a pre-publication is not made available first.
       
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    27. Ela Stefan

      Ela Stefan Member

      Tinnitus Since:
      11/2018
      Cause of Tinnitus:
      Ear Infection
      Do you want me to translate the above? 2028 and maybe not even then! Mark my words!
       
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    28. Chinmoku

      Chinmoku Member Benefactor Hall of Fame

      Tinnitus Since:
      10/2018
      Cause of Tinnitus:
      Started with a cold, possibly worsened by medication/noise
      This is what I was saying from the start, it's what is usually done and I'm glad this is happening here but is the pre-print about the trial? I haven't managed to read it yet under this 24/7 torture. Has anyone checked it?
      I won't be here by then. I don't know whether to laugh at all the factors that are keeping this treatment from being made available soon and at the wording of priorities in their totally uninformative communications, including the CEO's, or to cry. I think I'll go for crying.

      Depending on how long the quiet phase lasts (3-6 months?), the subsequent 180 days for technical clarifications, the industrialization and distribution, we are looking at a range of 1 year (unrealistically optimistic) - 3 years (moderately pessimistic). So July 2023 to July 2025, hoping for 2024, but it might take even longer than 2025 as you say. I won't make it that long, and with me a few others. It is what it is.
       
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    29. Uklawyer

      Uklawyer Member

      Tinnitus Since:
      03/2020
      Cause of Tinnitus:
      Medication - antidepressants
      No, it is not the pre-print for this trial. Dr. Shore's name is one of 7 on this paper, which studies whether inner hair cell (IHC) synaptopathy leads to hidden hearing loss in mice.

      Confused? I certainly am.
       
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    30. Bambam0
      Cool

      Bambam0 Member Podcast Patron Benefactor

      Tinnitus Since:
      2/2018
      Cause of Tinnitus:
      Drums
      At a risk of sounding naive, I have a lot of faith in this operation to quickly scale once results are published. The Auricle, Inc presentation late 2021 was a premature showing of their hand. They wouldn't have started to raise money otherwise.

      Assuming they are positive, once results are published I will personally do everything in my power (and I think a lot of folks here will too) short of storming their offices/lab, to get my hands on relief. I will not idly sit by knowing there is an effective treatment to this disaster of a condition just sitting behind red tape. There's way too much on the line.
       
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